Video Education With Result Dependent dIsclosure

Breast Cancer Clinical Trial

— VERDI  

Official title:

Video Education With Result Dependent dIsclosure

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05225428
• Other study ID #: 21-508
• Secondary ID: R01HG011928
• Status: Recruiting
• Phase: N/A
• Start date: August 4, 2022
• Est. completion date: September 1, 2026

Study information

• Verified date: November 2023
• Source: Dana-Farber Cancer Institute
• Contact: Huma Q. Rana, MD. MPH
• Phone: 617) 632-6292
• Email: humaQ_rana[@]dfci.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The overall study objective of this trial study is to identify and evaluate strategies to improve the accessibility of the video education with result dependent disclosure (VERDI) model, increasingly utilized as a pre-genetic testing (pretest) education alternative in clinical practice, to better serve a more diverse patient population at risk for hereditary cancers.

Description:

This study consists of two parts: - Qualitative assessment: - This part of the research study involves watching a brief educational video about genetic testing for inherited cancer risk (about 8 minutes) before completing a short interview by video or telephone with trained researchers. This interview will be digitally recorded for later review. Participation in the study will be considered complete after the interview is finished. The qualitative assessment study will recruit 20 total participants. - The data gathered from this study will inform the refinement and adaptation of the VERDI model for the subsequent randomized controlled trial. - Randomized control trial: - A randomized controlled trial (RCT) will evaluate the VERDI model vs. standard genetic counseling in 1000 participants

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1020
• Est. completion date: September 1, 2026
• Est. primary completion date: September 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age = 18 years
• Current or prior diagnosis of breast cancer, ovarian cancer, pancreatic cancer, prostate cancer, colorectal cancer, renal cancer, melanoma, or sarcoma
• Ability to understand spoken or written English or Spanish in a healthcare context
• Ability to understand and the willingness to sign a written informed consent document
• Black or Latinx (qualitative assessment study only)

Exclusion Criteria:

• Prior cancer genetic testing
• Prior germline genetic testing
• Active hematologic malignancy (e.g. chronic lymphocytic leukemia)
• Currently pregnant
• Currently incarcerated

Related Conditions & MeSH terms

• Breast Cancer
• Carcinoma, Renal Cell
• Colorectal Cancer
• Colorectal Neoplasms
• Genetic Testing
• Kidney Neoplasms
• Melanoma
• Ovarian Cancer
• Ovarian Neoplasms
• Pancreatic Cancer
• Pancreatic Neoplasms
• Prostate Cancer
• Prostatic Neoplasms
• Renal Cancer
• Sarcoma

Intervention

Behavioral:
• Video Education
Investigator-developed, professionally animated and produced 8-minute video (Video Education) summarizing the core educational components of a genetic counseling visit
• Genetic Counseling
Standard genetic counseling

Locations

Country	Name	City	State
United States	Dana Farber Cancer Institute	Boston	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Dana-Farber Cancer Institute	National Cancer Institute (NCI), National Human Genome Research Institute (NHGRI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Video Education Acceptability (Qualitative Interview Study)	Pre- and post-test of knowledge of hereditary cancer risk and cancer genetic counseling with qualitative patient interview question domains and instruments to assess understanding of language and imagery of video education as correlated with measures of health literacy.	3 Weeks